TGA goes public: IHRB must publish retractions

The Therapeutic Goods Administration has today made public the Regulation 9 Order that it served on IHRB. The Order demands that IHRB publish a retraction that informs the world that the advertisements which IHRB published, should not have been published because IHRB, ‘unlawfully made claims that the products could aid in hair regrowth…’ The TGA also Orders IHRB to notify the public thus by publishing a retraction which says, ‘We provided no evidence to support the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code.’

On 27 February 2014, the TGA made its decision which it published on its website on 9 May 2014. The TGA published the Decision under regulation 9 or the Therapeutic Goods Regulations 1990. This is what it wrote:

Institute of Hair Regrowth and Beauty (IHRB) Pty Ltd has been ordered to undertake a number of actions regarding newspaper and internet advertisements for various products, including but not limited to withdrawing the advertisements and publishing a retraction.

On 16 November 2012, the Panel issued a written determination that the advertisements contravened a section of the Therapeutic Goods Act 1989 (the Act) and breached sections the Therapeutic Goods Advertising Code 2007 (the Code).

On 23 February 2012, as a result of IHRB Pty Ltd not fully complying with the Panel’s determination, the Panel recommended the TGA delegate of the Secretary of the Department of Health (the Delegate) review the matter.

Following investigation, the Delegate’s decision was made on 27 February 2014 and amended on 12 March 2014.

The decision

The Delegate found that the newspaper advertisements:

1. related to therapeutic goods and, as required by the Therapeutic Goods Regulations 1990, should have been approved before being published, but were not approved, and therefore contravened 42C(1) of the Act

2. did not include an approval number in the bottom right hand side of the advertisements and therefore breached 6(4) of the Code.

The Delegate found that both the internet and newspaper advertisements:

3. contained claims that were incorrect, unbalanced and not previously verified by the sponsor and therefore breached section 4(1)(b) of the Code

4. were likely to arouse unwarranted and unrealistic expectations of product effectiveness and therefore breached section 4(2)(a) of the Code

5. were misleading or likely to be misleading and therefore breached section 4(2)(c) of the Code

6. exploited the lack of knowledge of consumers and was therefore in breach of section 4(2)(d) of the Code

7. contained statements to the effect that the products were guaranteed and miraculous and therefore breached 4(2)(g) of the Code

8. contained scientific information that was presented in a manner that was inaccurate, unbalanced and misleading and therefore breached 4(4) of the Code

9. contained comparisons to competing products that were misleading or likely to be misleading, without providing scientific evidence to support these statements, as well as claims that competing products were ineffective, and therefore breached 4(5) of the Code

10. contained claims made in testimonials that were misleading and could not be regarded as illustrating typical results and was therefore in breach of section 4(7) of the Code

11. did not include the statement ‘always read the label’ and therefore breached section 6(3)(c) of the Code

12. did not include the statements ‘use only as directed’ and ‘if symptoms persist see your doctor/healthcare professional’ and therefore breached section 6(3)(d) of the Code.

The order

The Delegate ordered IHRB Pty Ltd to:

a. withdraw both the newspaper and internet advertisements from further publication

b. withdraw any representations, including implied representations, that the advertised products are free from side effects, that they are effective in all cases of hair loss or for all sufferers of hair loss, that they can aid in hair regrowth on all parts of the scalp, that they can aid in the regrowth of natural hair for those experiencing hair loss, or could be effective in cases where other therapeutic goods such as Minoxidil had not been effective, together with any representations that DHT is ‘the balding gene’ or that the advertised goods block ‘the balding gene’

c. withdraw any representations that the advertised ‘natural and herbal’ goods can help people with genetic baldness regrow their own natural hair

d. not use any representations (b) and (c) above in any other advertisement

e. where representations have been provided to other parties, such as retailers or website publishers, and where there is a reasonable likelihood that the representations have been

f. published or are intended to be published by such parties, to advise them that the representations should be withdrawn arrange for the publication of a retraction on its website in the form noted below.

Conditions imposed on the order

a. Additionally, the Delegate imposed the following conditions under regulation 9(2) in relation to the order:

b. within 10 working days of being notified of this order, IHRB Pty Ltd will provide evidence of compliance with this order within 10 working days of being notified of this order, IHRB Pty Ltd will provide a written response indicating that it will continue to abide by this order.

Retraction notice

The below retraction notice is to appear on the advertiser’s website for no less than 180 days.

RETRACTION

An advertisement for Institute of Hair Regrowth and Beauty products, which we published on this website, should not have been published. In the advertisement we unlawfully made claims that the products could aid in hair regrowth and “block the balding gene”, that they would be effective on all parts of the scalp and for all consumers, and that they would be effective even where other products had failed.

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided no evidence to support the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code.

Following receipt of the Panel’s recommendation, the delegate of the Secretary for Health considered the information before her and decided to order that the Institute of Hair Regrowth and Beauty to publish this retraction.

IHRB APPEALS DECISION

Mr Sam Cohen has written to the Minister for Health to request a Review under Regulation 48 of the Therapeutic Goods Regulations 1990 (in relation to the ‘initial decision’ by the Delegate). Read about it at this link.

Years in breach of Sanctions

As at 19 August 2015, IHRB is 3 years & 289 days (that's 1,385 days) overdue on complying with the Sanctions set by the Complaints Resolution Panel which found that IHRB's ads have been 'unlawful, misleading, and unverified'. To learn more, see the 'Days in breach' section in the menu at the top of this page.

Days in breach of TGA Orders

As at 19 August 2015, Sam Cohen and IHRB are 544 days in breach of TGA Orders that demanded that IHRB stop its misleading, deceptive, and unlawful claims and to remove its statements from its website. The TGA also Ordered IHRB to publish a retraction on its website. Despite eventually publishing the retraction, IHRB is still in breach of these TGA Orders. Such a breach constitutes a criminal offence. To learn more, see the 'Days in breach' section in the menu at the top of this page.